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FDA 510(k)

PLEURAL DRAINAGE SYS #PDS-100-4

K-Number: K831849 · 1983-12-29

ApplicantAmerican Bentley
Decision Date1983-12-29
Product CodeCAC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PLEURAL DRAINAGE SYS #PDS-100-4 is the device name listed in this FDA 510(k) record. The listed applicant is American Bentley. It received FDA 510(k) clearance on 1983-12-29 under 510(k) number K831849. The device is classified under product code CAC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PLEURAL DRAINAGE SYS #PDS-100-4?

PLEURAL DRAINAGE SYS #PDS-100-4 is a medical device that received FDA 510(k) clearance on 1983-12-29. The listed applicant is American Bentley. The 510(k) number is K831849.

When did PLEURAL DRAINAGE SYS #PDS-100-4 receive FDA 510(k) clearance?

PLEURAL DRAINAGE SYS #PDS-100-4 received FDA 510(k) clearance on 1983-12-29, under 510(k) number K831849.

Who is the listed applicant for PLEURAL DRAINAGE SYS #PDS-100-4?

The FDA 510(k) record lists American Bentley as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PLEURAL DRAINAGE SYS #PDS-100-4?

The FDA product code for PLEURAL DRAINAGE SYS #PDS-100-4 is CAC.

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Related Devices (Code: CAC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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